Interbody fusion devices, systems and methods

ABSTRACT

According to some embodiments, a method of inserting a lateral implant within an intervertebral space defined between an upper vertebral member and a lower vertebral member includes creating a lateral passage through a subject in order to provide minimally invasive access to the intervertebral space, at least partially clearing out native tissue of the subject within and/or near the intervertebral space, positioning a base plate within the intervertebral space, wherein the base plate comprise an upper base plate and a lower base plate and advancing an implant between the upper base plate and the lower base plate so that the implant is urged into the intervertebral space and the upper vertebral member is distracted relative to the lower vertebral member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/865,154 filed Jan. 8, 2018, which is a continuation of U.S. patentapplication Ser. No. 14/774,640 filed Sep. 10, 2015, which is the U.S.National Phase under 35 U.S.C. § 371 of International ApplicationPCT/US2014/025035 filed Mar. 12, 2014, titled Lateral Interbody FusionDevices, Systems and Methods, which claims priority benefit under 35U.S.C. § 119(e) of U.S. Provisional Application No. 61/786,160, filedMar. 14, 2013. The entireties of all of the foregoing are herebyincorporated by reference herein.

BACKGROUND Field

This application relates generally to devices, systems and methods forthe treatment of the spine, and more specifically, to spinal implantsand related tools, systems and methods.

Description of the Related Art

Surgical approaches to the intervertebral space are utilized for avariety of indications and purposes, such as, for example, biopsy (e.g.,for evaluation of possible infection, other pathology, etc.), discectomy(e.g., for decompression of nerve roots, to prepare for subsequentfusion procedures, etc.), disc height restoration or deformitycorrection, disc replacement or repair (e.g., annular repair),discogram, gene therapy and/or other procedures or treatments.

Various approaches are currently used to access the interbody orintervertebral space of a patient's thoracic, lumbar and sacral spine.These include anterior approaches (ALIF) (e.g., open, mini-openretroperitoneal, etc.), lateral approaches (e.g., costotranversectomy,extreme lateral, etc.), posterolateral approaches (e.g., posteriorlumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion(TLIF), etc.) and axial approaches (e.g., axial lumbar interbodyfusion). Further, many minimally invasive and percutaneous approachesrely on radiographic landmarks with or without direct view to access atargeted interbody space. In addition, many, if not all, of thesecurrently used approaches require violation of the disc annulus toaccess the disc space.

Fusion surgery of the thoracic, lumbar and sacral spine is oftenperformed for a variety of indications, including degenerative jointdisease, deformity, instability and/or the like. Typically, traditionalfusion approaches involve relatively large, open incisions performedunder direct vision. Minimally invasive surgical techniques andcorresponding surgical implants have become more popular in an attemptto reduce morbidity and generally improve outcomes. Multiple variationsof percutaneous systems (e.g., pedicle screw and rod systems, facetscrew systems, etc.) have been developed. Such systems can allow forinstrumentation placement with fluoroscopic guidance (e.g., usingradiographically recognizable body landmarks) and/or other imagingtechnologies. Current fusion techniques, including those that utilizeopen and minimally invasive approaches, often require directvisualization. However, such techniques typically involve traversingspaces that are occupied by neural elements. Thus, these neural elementsneed to be retracted or otherwise moved during the execution of spinalprocedures that precede implantation (e.g., annulotomy, discectomy, discspace and/or vertebral endplate preparation, etc.). Retraction ofsensitive neural elements can also be required during the delivery of animplant to the spine.

These approaches typically require contact and retraction of nerve rootsand/or sensitive visceral organs, blood vessels and/or other sensitiveportions of the anatomy. Contact and retraction of these structures canplace them at risk, thereby increasing the likelihood of complicationsand damage to a patient. Accordingly, a need exists for improvedapproaches for spinal fusion and/or access to intervertebral spaces.

SUMMARY

According to some embodiments, a method of inserting an implant withinan intervertebral space defined between an upper vertebral member and alower vertebral member comprises positioning a plate system within theintervertebral space, wherein the plate system comprises an upper plateand a lower plate, and

advancing an implant between the upper plate and the lower plate so thatthe implant is urged into the intervertebral space, the upper plateengages the upper vertebral member, and the lower plate engages thelower vertebral member, wherein upon advancement of the implant betweenthe upper and lower plates, the upper vertebral member is distractedrelative to the lower vertebral member.

According to some embodiments, advancing an implant between the upperand lower base plates comprises using a device or tool (e.g., mechanicaltool, pneumatic tool, etc.). In one embodiment, advancing the implantbetween the upper plate and the lower plate comprises advancing theimplant at least partially through a guiding assembly (e.g., betweenupper and lower members of the assembly). In one embodiment, the guidingassembly is removably secured and/or aligned with the upper and lowerplates.

According to some embodiments, the guiding assembly comprises upper andlower guiding members or plates, wherein the upper and lower guidingmembers or plates are configured to removably engage correspondingportions of the upper and lower plates when the implant is advanced intothe intervertebral space. In some embodiments, advancing the implantbetween the upper and lower plates deploys at least one engagementmember or feature of at least one of the upper plate or the lower plate,wherein the at least one engagement member or feature is configured toengage at least a portion of the an adjacent vertebral member. In someembodiments, the at least one engagement member or feature comprises atooth, spike, barb and/or the like.

According to some embodiments, the implant is configured to be advancedbetween the upper and lower plates using a rail system. In oneembodiment, the rail system comprises at least one protruding member orfeature on the implant and at least one corresponding groove or recesson the upper plate or lower plate, wherein the at least one protrudingmember or feature is configured to (e.g., slidably or otherwise) movewithin the at least one corresponding groove or recess on the upperplate or lower plate. In some embodiments, the rail system comprises atleast one groove or recess on the implant and at least one correspondingprotruding member or feature on the upper plate or lower plate, whereinthe at least one protruding member or feature is configured to (e.g.,slidably or otherwise) move within the at least one corresponding grooveor recess.

According to some embodiments, the implant comprises a generally smoothouter surface. In some embodiments, the implant does not comprise anyteeth or other engagement features. In some embodiments, the implantcomprises PEEK, stainless steel, titanium, other metals or alloys, otherpolymeric materials and/or the like.

According to some embodiments, the upper and lower plates comprise atleast one metal or alloy and/or a polymeric material (e.g., PEEK). Insome embodiments, the at least one metal or alloy comprises titanium,stainless steel and/or any other medical grade metal or alloy. In someembodiments, the lower plate and/or the upper plate is bead-blasted oris otherwise at least partially roughened (e.g., along one or moresurfaces that are configured to contact and engage native vertebraltissue of the subject). In some embodiments, the lower plate and/or theupper plate comprises an ingrowth surface (e.g., along one or moresurfaces that are configured to contact and engage native vertebraltissue of the subject).

According to some embodiments, the method further comprises securing atleast one screw or other fastener through an opening of the implant(and/or an adjacent plate, washer or other member) after the implant hasbeen properly secured within the intervertebral space. In someembodiments, the at least one screw passes through at least a portion ofthe upper or lower plate. In some embodiments, the at least one screwpasses through at least a portion of the upper or lower vertebral member(and/or an adjacent plate, washer or other member).

According to some embodiments, the method further comprises creating apassage (e.g., lateral passage) through a subject in order to provideminimally invasive access to the intervertebral space. In oneembodiment, the method further comprises clearing out native tissue ofthe subject within and/or near the intervertebral space (e.g., using oneor more rasps and/or other native tissue removal tools or methods).

According to some embodiments, a spinal fusion system comprises a platesystem configured for placement within an intervertebral space of asubject, wherein the plate system comprises an upper plate and a lowerplate, an implant configured to be advanced and positioned between theupper plate and the lower plate to secure the implant within theintervertebral space, wherein, when the implant is advanced between theupper plate and the lower plate, the upper plates engages the uppervertebral member, and the lower plate engages the lower vertebralmember, and wherein, upon advancement of the implant between the upperand lower plates, the upper vertebral member is distracted relative tothe lower vertebral member.

According to some embodiments, the system additionally comprises aguiding assembly having upper and lower slides, wherein the upper slideis configured to removably couple to the upper plate, and wherein thelower slide is configured to removably couple to the lower plate. In oneembodiment, the upper plate and/or the lower plate comprises at leastone engagement member (e.g., tooth, spike, barb, etc.) configured toengage a portion of the adjacent vertebral member when the implant hasbeen advanced between the upper and lower plates.

According to some embodiments, the implant is configured to be advancedbetween the upper and lower plates using a rail system. In oneembodiment, the rail system comprises at least one protruding member orfeature on the implant and at least one corresponding groove or recesson the upper plate or lower plate, wherein the at least one protrudingmember or feature is configured to slidably move within the at least onecorresponding groove or recess on the upper plate or lower plate. Insome embodiments, the rail system comprises at least one groove orrecess on the implant and at least one corresponding protruding memberor feature on the upper plate or lower plate, wherein the at least oneprotruding member or feature is configured to slidably move within theat least one corresponding groove or recess.

According to some embodiments, the implant comprises a generally smoothouter surface. In one embodiment, the implant does not comprise anyteeth or other engagement features. In some embodiments, the implantcomprises PEEK, titanium and/or any other metal, alloy and/or polymericmaterial. In one embodiment, the upper and lower plates comprise atleast one metal (e.g., titanium, stainless steel, etc.), alloy and orpolymeric material (e.g., PEEK).

According to some embodiments, the system further comprises at least onescrew or other fastener, the screw or fastener being configured to besecured through an opening of the implant after the implant has beenproperly secured within the intervertebral space. In one embodiment, theat least one screw passes through at least a portion of the upper orlower plate. In some embodiments, the screw passes through at least aportion of the upper or lower vertebral member.

According to some embodiments, a method of inserting a lateral implantwithin an intervertebral space defined between an upper vertebral memberand a lower vertebral member includes creating a lateral passage througha subject in order to provide minimally invasive access to theintervertebral space, at least partially clearing out native tissue ofthe subject within and/or near the intervertebral space, positioning abase plate within the intervertebral space, wherein the base platecomprise an upper base plate and a lower base plate and advancing animplant between the upper base plate and the lower base plate so thatthe implant is urged into the intervertebral space and the uppervertebral member is distracted relative to the lower vertebral member.

According to some embodiments, advancing an implant between the upperand lower base plates comprises using a mechanical device (e.g., athreaded-system using a rotatable handle to advance a rod or otheractuator, manual or mechanically-assisted device, etc.). In someembodiments, the implant comprises at least one groove and at least oneof the upper base plate member and the lower base plate member comprisesat least one protruding feature, the at least one groove beingconfigured to align and move relative to the at least one protrudingfeature. In some embodiments, the implant is delivered through the baseplate using a rail or other alignment system. In some embodiments, theimplant comprises at least one of PEEK, titanium and/or the like. Insome embodiments, the base plate comprises titanium, stainless steel oranother medically-acceptable metal or alloy.

According to some embodiments, the method further includes securing atleast one screw (e.g., 1, 2, 3, 4, more than 4, etc.) through an openingof the implant after the implant has been properly secured within theintervertebral space. In one embodiment, the screw also passes throughat least a portion of the upper or lower base plate member and/or theupper or lower vertebra.

The methods summarized above and set forth in further detail belowdescribe certain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “advancing an implant” include“instructing advancing an implant.”

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentapplication are described with reference to drawings of certainembodiments, which are intended to illustrate, but not to limit, thepresent inventions. It is to be understood that these drawings are forthe purpose of illustrating the various concepts disclosed herein andmay not be to scale.

FIG. 1 schematically illustrates one embodiment of a spinal implantsystem with the implant not positioned within the target intervertebralspace;

FIG. 2 illustrates the system of FIG. 1 with the implant positionedbetween the base plate members and implanted within the intervertebralspace;

FIGS. 3A and 3B illustrate various views of a base plate of an implantsystem according to one embodiment;

FIG. 4 illustrates a side view of a spinal implant system according toone embodiment;

FIGS. 5A-5C illustrate various views of one embodiment of a base platefor use in a spinal implant system;

FIGS. 6A and 6B illustrate various views of one embodiment of an implantconfigured for use in a spinal implant system;

FIG. 7A illustrates one embodiment of a base plate configured for use ina spinal implant system;

FIG. 7B illustrates one embodiment of an implant configured to be usedtogether with the base plate of FIG. 7A;

FIGS. 8A-8C illustrate various time-sequential side views during aspinal implant procedure according to one embodiment;

FIGS. 9A-9D illustrate different views of a fusion system according toone embodiment;

FIGS. 10A and 10B illustrate different views of one embodiment of animplant configured for use with a spinal fusion system;

FIG. 11 illustrates a partial cross-sectional view of an implantpositioned within a guiding assembly and upper and lower plates,according to one embodiment;

FIG. 12 illustrates a perspective view of one embodiment of an implantsecured between upper and lower plates of a fusion system;

FIG. 13 illustrates a perspective view of one embodiment of an implantsecured between upper and lower plates of a fusion system reinforced bytwo screws; and

FIG. 14 illustrates a schematic top view of a portion of a guidingassembly and a corresponding plate configured for use with a spinalfusion system according to one embodiment.

DETAILED DESCRIPTION

A variety of examples described below illustrate various configurationsthat may be employed to achieve desired improvements. The particularembodiments and examples are only illustrative and not intended in anyway to restrict the general concepts presented herein and the variousaspects and features of such concepts.

According to some embodiments, the present application discloses variousdevices, systems and methods for accessing the intervertebral orinterbody space of a patient's spine and/or performing certainprocedures related to spinal fusion using minimally invasive surgery(MIS) techniques. As discussed in greater detail herein, theintervertebral or interbody space of the targeted portion of thepatient's spine is accessed and/or treated minimally invasively using,at least in some embodiments, a lateral approach. The terms“intervertebral space” and “interbody space” are used interchangeablyherein, and generally refer to the space, gap or region between adjacentvertebral members. By way of example, as illustrated in FIG. 1, theintervertebral space 14 between adjacent vertebrae 10, 12 can beaccessed using one or more lateral openings or passages createdlaterally through the subject's anatomy (e.g., using one or more accessdevice, such as, retractors, dilators, etc.). In some embodiments, suchopenings or passages are created, accessed and/or otherwise use usingMIS techniques or procedures. The various devices, systems and methodsdisclosed herein, and variations thereof can be applied to any type ofspinal implant, including, but not limited to, a lateral interbodyfusion implant, a transforaminal lumbar interbody fusion (TLIF) implant,an oblique TLIF implant, a posterior lumbar interbody fusion (PLIF)implant, an anterior lumbar interbody fusion (ALIF) implant and/or thelike. Accordingly, the various embodiments disclosed herein can be in avariety of MIS or non-MIS approaches, including, without limitation,lateral, TLIF, posterior, ALIF and/or the like.

FIG. 1 schematically illustrates one embodiment of a spinal fusion orstabilization system 50. As shown, the system 50 can include upper andlower plates (e.g., endplate members) 300 or other members that arepositioned along the endplates of the upper and lower vertebral members10, 12. In some embodiments, the plates 300 generally extend across theentire or substantially the entire width of the vertebrae 10, 12. Insome embodiments, the plates 300 are the same length or substantiallythe same length as the spinal implant 200 that will be delivered betweenthe plates 300 and into the intervertebral space 14. For example, theplates 300 and/or the implant 200 can be approximately 40 to 60 mm long(e.g., 40, 45, 50, 55, 60 mm, lengths between the foregoing ranges,etc.). In other embodiments, however, the length of the implant isgreater than 60 mm or less than 40 mm, as desired or required.

According to some embodiments, the upper and lower plates comprise atleast one metal or alloy and/or a polymeric material (e.g., PEEK). Insome embodiments, the at least one metal or alloy comprises titanium,stainless steel and/or any other medical grade metal or alloy. In someembodiments, the lower plate and/or the upper plate is bead-blasted oris otherwise at least partially roughened (e.g., along one or moresurfaces that are configured to contact and engage native vertebraltissue of the subject). In some embodiments, the lower plate and/or theupper plate comprises an ingrowth surface (e.g., along one or moresurfaces that are configured to contact and engage native vertebraltissue of the subject). In some arrangements, such a configuration canassist to prevent movement between the plate and the vertebral body.

In some embodiments, as illustrated in FIG. 9A, each of the upper andlower plates 300 comprises at least one central opening O that can atleast partially align with and provide access to (e.g., from a spacegenerally between the upper and lower plates) to native tissue of theadjacent vertebral members V1, V2 of the subject.

In some embodiments, once the plates (e.g., endplate members) 300 havebeen properly positioned within the target intervertebral space 14, theimplant 200 can be delivered (e.g., laterally) between the upper andlower plates or other members 300. The delivery of the implant 200between the plates 300 can be performed with or without the use of amechanical delivery tool (e.g., by using a threaded delivery device orother device providing for mechanical advantage, etc.). Regardless ofthe exact manner in which the implant 200 is advanced into theintervertebral space 14 between the upper and lower plates 300, theupper and lower plates 300 can provide one or more advantages orbenefits. For example, the use of the plates 300 can help distributeforces and moments along a larger surface area. This is generallyillustrated by the schematic force distribution diagram F in FIG. 2.Accordingly, the likelihood of potentially damaging localized forces,moments and/or other stresses on a particular portion or area of theadjacent vertebrae 10, 12 can be reduced or eliminated. The risk ofdamage to bone and/or other native tissues to the subject during afusion procedure can be further reduced by advancing the implant 200,and thus separating the upper and lower plates 300 in a morepredictable, gentler manner (e.g., as opposed to traditional methods ofusing great force to position an implant within a target intervertebralspace).

Further, in some embodiments, the use of the upper and lower plates 300can facilitate the delivery of the implant 200 within the targetinterbody space with greater ease and less resistance. As a result, theendplates and other portions of the adjacent vertebrae 10, 12 can beprotected against shearing, fractures and/or other damage. This can beespecially important when the implant 100 causes distraction (e.g.,separation or opening) of a collapsed or partially collapsed interbodyspace 14, as represented by the arrows 16 in FIG. 2.

As discussed herein, one or both sides of the upper and/or lower platescan include spikes, teeth, other protruding members and/or otherengagement features. For example, if such engagement features arepositioned along the top of the upper plate or the bottom of the lowerplate, the engagement features can be advanced into the adjacentendplate(s) as the implant 200 is moved between the plates 300. This canhelp secure the plates to the adjacent vertebrae 10, 12. In someembodiments, engagement features can be positioned along the oppositesurfaces of the plates (e.g., along the bottom of the upper plate and/oralong the top of the lower plate). Such engagement features can helpprevent or reduce the likelihood of relative movement between theimplant 200 and the plates 300 following implantation. In otherembodiments, as discussed in greater detail herein with reference to,e.g., FIGS. 9A to 12, the implant 200 and the adjacent surfaces of theupper and lower plates 300 can include recesses, protrusions, othercomponents of a “rail” system and/or any other feature to help maintaina particular orientation between the plates and the implant during useand/or after implantation, to help prevent or reduce the likelihood ofany undesirable relative movement between the plates and the implantduring use and/or after implantation and/or the like. Thus, the platesand/or the implant can include one or more other features, such as, forexample, rails or guiding members (e.g., to assist in moving the implantmore easily and more predictably between the plates), tabs or otherportions configured to receive one or more screws or other fasteners(e.g., to further secure the system 100 to the spine after delivery intothe intervertebral space) and/or the like.

FIGS. 3A and 3B illustrate different views of one embodiment of upperand lower plates (e.g., base plates or endplate members) 300 configuredfor use in a spinal fusion system. As shown, the base plates 300 caninclude upper and lower plates 310, 314. The base plates 300 can beshaped, sized and configured to span across an entire width of thesubject's vertebrae 10, 12. As discussed herein, the upper and/or lowerplates can include one or more openings to provide access to theadjacent native vertebral surfaces of the subject after implantation. Insome embodiments, the base plates 300 extend beyond one or more side ofthe vertebral periphery or do not extend to the lateral edge of thevertebrae (e.g., are short by a certain clearance distance from one ormore lateral edges of the vertebrae). In some embodiments, where theplates 300 extend beyond a perimeter of the upper and/or lowervertebrae, a portion of the plate 300 can be configured to be removed ormanipulated after implantation. For example, in some embodiments, insuch a configuration, a protruding portion of the plate can be folded orbent (e.g., either upwardly or downwardly) to move the folded or bentportion either toward or away from the intervertebral space. In someembodiments, such a bent or folded portion can include one or moreopenings or other holes that can be used to place a bone screw of otherfastener therethrough (e.g., to secure that portion of the plate to anadjacent vertebral member, to another bent or folded plate used in afusion system, to a separate washer or other plate member and/or thelike.

As shown in FIG. 3A, the plate members 310, 314 can include one or moreprotruding members (e.g., teeth, rails, other engagement members orfeatures, etc.) 320 that extend toward each other (e.g., toward theintervertebral space). Such protruding members can be fixed or movable.For example, in some embodiments, the protruding members 320 aredeployable (e.g., before, during or after advancement of an implantbetween the base plates 300). In other embodiments, plate members 300can include teeth, protruding members or other engagement features ordevices along their opposite surfaces (e.g., along the top of the upperplate, along the bottom of the lower plate, etc.), either in lieu of orin addition to having inwardly-directed protruding members. As discussedin greater detail herein, outwardly-projecting protruding members 320 onthe plates (e.g., FIG. 9A) can help secure the plates to the adjacentsurfaces of the upper and lower vertebral members of the subject beingtreated. This can advantageously provide one or more clinical benefits,such as, for example, the preservation of long-term implantation (e.g.,reducing the likelihood of dislodgement or movements of the implantsystem within the target intervertebral space following implantation).

With continued reference to FIG. 3A, a system can include a guidingassembly 500 that can be strategically positioned along one of thelateral ends of the targeted intervertebral space. The guiding assembly500 can include an alignment device 510 that may comprise one or morealignment components 514, 516. Regardless of its exact configuration anddesign, the alignment device 510 can advantageously permit a surgeon orother practitioner to accurately position the guiding assembly 500 forthe subsequent delivery of an implant therethrough and between the baseplates 300. As discussed in greater detail herein, the guiding assembly500 can include upper and lower alignment members or slide members 514,516, which are generally aligned with the upper and lower plates 300. Insome embodiments, each alignment member 514, 516 can be configured toremovably attach to the corresponding plate 300 to help advance andposition the plates 300 within the targeted intervertebral space (e.g.,minimally invasively). In some embodiments, the distal ends of thealignment members or slides 514, 516 can be configured to be slidablyreceived within slots, recesses or other portions of the plates 300.Thus, the guiding assembly 500 can be temporarily coupled to the plateswhen the plates are being advanced into the intervertebral space andwhen the implant is subsequently delivered between the plates (e.g., asdiscussed in greater detail below). However, in some embodiments, oncethe implant 200 has been properly advanced between the plates and theimplant system has been adequately secured between the adjacentvertebrae, the alignment members or slides 514, 516 can be easilyretracted (e.g., rearwardly or proximally) relative to the plates andimplant for removal from the subject's anatomy and completion of thefusion procedure.

With continued reference to FIG. 3A, the alignment members or components514, 516 and/or one or more other portions or components of the assemblycan include a flange or other abutment or securement portion 518. Such aflange 518 can be fixedly or movable positioned along the adjacentvertebrae 10, 12 of the subject to ensure proper alignment into thetargeted intervertebral space. In other arrangements, as noted herein,the alignment members and other components of the guiding assembly areconfigured to completely decouple from the plates and the implant afterimplant has been properly delivered into the target intervertebralspace.

As illustrated in FIG. 4, an implant 200 can be delivered between theplates 300 and into the intervertebral space using a mechanicaladvancement device. Therefore, in some embodiments, the guiding assembly500 can advantageously comprise a mechanical advancement device orfeature. For example, in FIG. 4, the guiding assembly comprises athreaded delivery portion that is configured to advance an implant 200between the base plate members 310, 314 by turning a rotatable handle orother advancement tool. As a user rotates the handle 520, a rod 522 orother actuator is moved forwardly (e.g., distally) in the direction ofthe implant 200. The implant 200 can be directly or indirectly coupledto the actuator 522 via one or more coupling or other detachableconnections 526, as desired or required. As the rod is advanceddistally, the implant (e.g., lateral cage) can be guided between thebase plate members 310, 314 and into the intervertebral space.Consequently, the base plate members 310, 314 separate and are urgedtoward the adjacent endplates of the vertebrae. In some embodiments, asillustrated schematically in FIG. 4, the implant can include a taper(e.g., bullet design) along its distal end to facilitate initial entryand subsequent distraction and separation of the base plate 300.

In other embodiments, one or more other devices can be used to helpadvance the implant between the plates. For example, a pneumatic tool(e.g., air or liquid driven tool) can be used to apply the requiredforce on the implant to move it into position. Any other type ofuser-assisting device or system can be used to help advance the implantbetween the plates, such as, for example, other types of mechanicaldevices, electromechanical devices, motorized devices, pumps and/or thelike.

With continued reference to FIG. 4, the guiding assembly 500 can includeone or more structures 510 that help ensure that the implant stayswithin the guiding assembly 500 and maintains its alignment with theintervertebral space during advancement between the plates. Suchstructure 510 can, for example, help reduce any deflection ormisdirection of the implant's leading end during distal delivery to theintervertebral space, especially when relatively high forces are beingexerted on the implant (e.g., that may otherwise cause the implant tomove out of alignment with the base plates). In some embodiments, theimplant 200, the base plates 300 and/or any other portion of the systemcan include rails or other alignment features that further help maintaina proper alignment of the implant during advancement between a subject'svertebrae. As discussed in greater detail herein, the guiding assemblycan include alignment members (e.g., slides) 514, 516 that removablysecure to the plates 300 and provide a reliable and predictable path foradvancement of the implant within the intervertebral space. In someembodiments, such slides 514, 516 can be subsequently removed anddecoupled or separated (e.g., slidably, mechanically, etc.) from theplates 300.

FIGS. 5A-5C illustrate various views of a different embodiment of asystem comprising base plates 300 for receiving a spinal implant. Asshown, an alignment device 510′ can be positioned relative to one ormore of the adjacent vertebrae 10, 12 and subsequently secured theretousing additional fasteners or other connection devices or methods. Forexample, one or more screws S or other fasteners can be used to secureone or more portions of the alignment device to the upper and/or lowervertebral members of the subject. In some embodiments, the alignmentdevices 510′ comprise one or more flanges or plates P through which thescrews S or other fasteners can be placed. Once the alignment device510′ has been secured to the subject, the implant can be deliveredbetween the base plate members 310, 314. The alignment device 510′, baseplate 300 and/or other portions of the system can be left in place afterthe implant has been secured between the subject's vertebrae. In otherembodiments, however, one or more components of the system (e.g., baseplate 300, screws, etc.) can be left in place after implantation, and insome instances, may help reinforce or otherwise benefit the treatedarea.

One embodiment of an implant 200 that can be used with the spinal fusionsystems disclosed herein is illustrated in FIGS. 6A and 6B. As bestshown in the top view of FIG. 6B, the implant 200 can include one ormore open regions or chambers 210 for holding a grafting material. Inaddition, the implant can include one or more grooves 220 or otherrecesses along its anterior and/or posterior walls. In some embodiments,such grooves 220 or other features can align and mate with correspondingrails, protrusions or features of the base plate 300. Accordingly, thegrooves, rails and/or other features can help safely, accurately andpredictably move the implant 200 into the target intervertebral space(e.g., between adjacent base plate members). In other embodiments,however, the rail system between the implant 200 and the adjacent plates300 can be reversed. For example, as illustrated in the embodiments ofFIGS. 9A to 16, the implant can include one or more protruding or raisedportions that generally align and correspond to grooves or recessesalong the adjacent surfaces of the plates 300. Regardless of the exactorientation and design of the rail system, such a system can help ensurethat an implant is accurately and safely delivered to a targetintervertebral space.

In some embodiments, the implants disclosed herein comprise PEEK,titanium or other acceptable materials. For example, in someembodiments, the implant 200 comprises a metal edge plate or othersurface or feature 226 through which one or more screws (not shown inFIGS. 6A and 6B) can be subsequently delivered to secure the implant 200to one or more of the subject's vertebrae. In some arrangements, theplate 226, which can be positioned along the proximal end of the implant200, comprises titanium or other acceptable metal or alloy and/or otherrigid or semi-rigid material.

FIG. 7A illustrates a side view of one embodiment of a base plate 300comprising upper and lower plate members 310, 314. As shown, the baseplate members 310, 314 can include one or more protruding members 320.Such protruding members 320 can include tabs, bumps, spikes, teeth,grasping members, engagement members, other sharp, smooth and/or roundedfeatures or members and/or the like. In some embodiments, the protrudingmembers 310, 314 can be fixed (e.g., non-movable, non-deployable, etc.)and/or movable (e.g., selectively retractable, deployable, etc.). Forexample, in some embodiments, the protruding members 320 of the upperand/or lower plate members 310, 314 are deployable using a mechanicalconnection, a temperature change and/or using some other mechanism ofaction, device or method. In some embodiments, such protruding members320 can help engage the plates 300 to the implant 200. In otherembodiments, however, the protruding members 320 can be configured toreverse their orientation (e.g., in a direction away from the interiorof the intervertebral space or toward the adjacent vertebral member)when the implant is advanced over the protruding members duringimplantation. Therefore, in some embodiments, as the implant is advancedbetween the plates 300, the protruding members 320 can deform orotherwise change orientation so as to engage the upper and lowervertebral members. This can provide positive engagement of the platesinto the adjacent vertebrae, which may, in some circumstances, result ina more secure implantation of the system within the subject.

FIG. 7B illustrates a top view of one embodiment of an implant 200 thatis configured to be used with the base plate 300 of FIG. 7A.Specifically, as shown, the implant 200 can include one or more grooves,holes, recesses or other openings 240 that are shaped, sized andotherwise configured to receive corresponding protruding members 320 ofthe base plate 300. As discussed in greater detail herein, in otherarrangements (e.g., FIG. 9A), an implant 200 can include one or moreprotruding members or features that are sized, shaped and otherwiseconfigured to engage and move within grooves or corresponding recessesof the adjacent plates 300.

With continued reference to FIG. 7B, the protruding members 320′ of thebase plate 300 can include a curved leading edge to permit the groove240 of the implant 200 to only temporarily engage the member 320′ as theimplant is advanced into the target intervertebral space. Thus, theprotruding members can sequentially engage and disengage a groove on theimplant (e.g., in a ratcheting manner). In some embodiments, the implantcan only be permitted to be advanced in one direction (e.g., distally).Such an embodiment can be helpful when using base plates 300 that havefixed protruding members 320. In embodiments comprising deployableprotruding members, the need for such ratcheting system (e.g., thatpermits movement in at least one direction) may not be needed, as theprotruding members 320 can be selectively deployed only when the implantis properly positioned between the base plate members.

In some embodiments, the use of protruding members and correspondinggrooves or other recesses can help with guiding an implant 200 betweenadjacent base plate members (e.g. during delivery). Such embodiments canalso assist in securely maintaining the implant in its implantedposition following the delivery of the implant in the targetintervertebral space.

As illustrated schematically in FIGS. 8A-8C, a lateral implant device inaccordance with the various embodiments disclosed herein, can bedelivered to the target intervertebral space minimally invasively (e.g.,through one or more tissue dilators, cannulas or other openings). Asdiscussed in greater detail herein, once the plates 300 have beenproperly positioned between the subject's vertebrae 10, 12, a guidingassembly 500 can be positioned through a dilator or other access deviceand in general alignment with the targeted intervertebral space. Theimplant can be advanced using a mechanical device (as illustrated inFIG. 8A), manually and/or using some other method or device. Further,the implant and base plate can include one or more features or members(e.g., rails, grooves, etc.) to assist in accurately moving the implantin the desired anatomical location of the subject's spine. Once theimplant has been advanced between the base plate members 310, 314 andproperly within the intervertebral space, the guiding assembly 500 canbe removed.

With reference to FIG. 8B, in some embodiments, a screwdriver or othermechanical device 600 can be delivered through a dilator, cannula orother access device C to engage and advance one or more screws S orother fasteners through corresponding openings along the proximal end ofthe implant 200. In some embodiments, the use of such fasteners canassist with maintaining the position of the implant 200 relative to thesubject's spine following implantation, as shown in FIG. 8C. The screwsS can be routed through the implant, the base plate and/or the vertebra,as desired or required. However, in other embodiments, the use of screwsS or other fasteners is not needed or required to maintain the implantedimplant between the base plate members and the adjacent vertebrae. Insome embodiments, a total of four fixation screws are positioned throughthe proximal end of the implanted implant (e.g., two above and twobelow). In some embodiments, the screws or other fasteners can be passedthrough openings of one or more plates or washers that at leastpartially cover or otherwise shield the intervertebral space, provideadditional structural support and/or provide one or more other benefitsor advantages. In other embodiments, more or fewer screws or otherfasteners can be used, as desired or required.

In order to remove disk material, cartilage, endplate or other vertebraltissue and/or native tissue of a subject during an implantationprocedure, a surgeon or other practitioner can use any of the rasping orother tissue cutting devices and methods disclosed in U.S. patentapplication Ser. No. 13/422,816, titled TRANSPEDICULAR ACCESS TOINTERVERTEBRAL SPACES AND RELATED SPINAL FUSION SYSTEMS AND METHODS,filed Mar. 16, 2012 and published as U.S. Publ. No. 2012/0265250 on Oct.18, 2012, and U.S. Provisional Patent Application No. 61/783,839, titledDEVICES AND METHODS FOR TRANSPEDICULAR STABILIZATION OF THE SPINE andfiled on Mar. 14, 2013, the entireties of both of which are herebyincorporated by reference herein and made a part of the presentapplication.

FIGS. 9A-9D illustrate different views of another embodiment of a spinalfusion system 100. As discussed above with reference to otherarrangements, the system 100 can include upper and lower plates 300 thatare sized, shaped and otherwise configured to be positioned between theadjacent vertebral members V1, V2 where fusion is targeted. The system100 further comprises a guiding assembly 500. In some embodiments, asdiscussed above, the alignment members (e.g., slides) 514, 516 of theguiding assembly 500 are configured to releasably secure or otherwisetemporarily engage to or with the plates 300. Accordingly, theplate-slide assembly can be placed within the subject and advanced tothe target intervertebral space. For example, in some embodiments, oneor more distal portions of the alignment members or slides 514, 516 canreleasably attach to and/or slide within adjacent portion(s) of theplates 300. In other embodiments, such as the system 100A illustrated inFIG. 14, one or both of the slides 514A, 516A comprise an extensionportion 518A that extends into the targeted intervertebral space andprovides a surface over which the implant can move when the implant isadvanced in the vicinity of the vertebral members. The use of suchextension portion 518A can help maintain the graft material within theinterior chambers of the implant during advancement to theintervertebral space. Accordingly, the use of extension portions 518A orsimilar members or features can be advantageously incorporated into anyimplant system embodiments disclosed herein or equivalents thereof.

With continued reference to FIGS. 9A-9D, the system 100 can comprise adelivery device or feature 520 that can facilitate the surgeon or otherpractitioner with the advancement of the implant 200 through the guidingassembly and into the intervertebral space (e.g., between the plates300). In some embodiments, the implant 200 is initially inserted at ornear the proximal end of the guiding assembly 500, generally between thealignment members or slides 514, 516. Then, once the surgeon hasadvanced the guiding assembly 500, and in some configurations, theplates 300 and the implant 200 to which the assembly 500 is engaged,through the subject's anatomy (e.g., through an access device), thesurgeon can begin to move the implant distally by manipulating thehandle or other portion of the guiding assembly.

For example, with reference to the side view of FIG. 9B, by turning thehandle 522 of the guiding assembly 500, the threaded rod 526 can moverelative to a housing 528. Such manipulation of the handle 522 canresult in moving the distal end 524 of the rod 526 forwardly (e.g.,distally) so as to engage the implant 200 positioned between the slides514, 516 and exert a force on the implant 200. In some embodiments, thedistal end 524 of the rod comprises a coupling or other blunt member orfeature that can help avoid damage to the adjacent portion of theimplant 200 during the advancement process.

As illustrated in FIG. 9A, as the implant is advanced distally withinthe interior of the guiding assembly 500 (e.g., between the upper andlower slides or alignment members 514, 516), the distal end of theimplant 200 will reach the proximal end of the plates 300 that have beenpositioned within the intervertebral space. With continued advancementof the implant 200 in the distal direction (e.g., as schematicallyrepresented by arrow 50 in FIG. 9C), the implant 200 will move betweenthe upper and lower plates 300, causing the plates 300 to separate apartfrom each other, in certain arrangements. In some configurations, theimplant 200 is moved far enough distally between plates 200 so that isspans across an entire length or substantially an entire length of theplates 300.

FIGS. 10A and 10B illustrate one embodiment of an implant 200 that isconfigured to be used with one or more of the fusion systems disclosedherein, including the system 100 of FIGS. 9A-9D. As shown, the implant200 can include one or more internal chambers 210. Such chambers 210 canbe sized, shaped and otherwise configured to be at least partiallyfilled with graft material (not shown) before the implant 200 isadvanced between the plates 300. As noted above, the implant 200 cancomprise one or more materials, such as, for example, PEEK, titanium,other metals or alloys, other polymeric materials and/or the like.

With continued reference to FIGS. 10A and 10B, the implant 200 caninclude one or more protrusions, ridges or similar members or features220 that extend at least partially along one or more surfaces of theimplant 200. In some embodiments, such protrusions 220 can be sized,shaped and otherwise configured to be moved relative to correspondinggrooves or recesses of the upper and lower plates 300 and/or the upperand lower slides or alignment members 514, 516 of the guiding assembly500. For example, as shown in the embodiment of FIG. 11, the upper plateand/or the lower plate 300 can include one or more grooves or recesses320 that are configured to receive the protrusions 220 of the implant200 when the implant is properly positioned within the guiding assembly500 and between the plates 300. Although not illustrated in the view ofFIG. 11, the grooves or recesses 320 can extend proximal to the plates300 and be present, either continuously or intermittently along at leasta portion of the slides 514, 516 of the guiding assembly 500. Thus, theimplant 200 can be predictably moved between the slides 514, 516 and theplates 300 to properly, safely and securely position the implant 200within a targeted intervertebral space.

In the embodiments illustrated herein, the guiding assembly 500 and theplates 300 are generally straight, and the path that the implant followsthrough the guiding assembly 500 is generally linear. However, in otherembodiments, the grooves or recesses of the guiding assembly and/or theplates (and thus, the corresponding protruding members or features ofthe implant 200), or vice versa, can be at least partially curved, sothat the implant is moved along a non-linear pathway. In someembodiments, the non-linear pathway can comprise a continuous curve(e.g., with a constant or variable diameter along the length of thecurve). However, in other arrangements, the curve or turn is more abrupt(e.g., piecemeal turn or short radius turn) so as to avoid a longer,sweeping turning radius. Such embodiments can be helpful with certainMIS approaches where an implant needs to be maneuvered more carefullyand precisely around sensitive nerve structures, such as, for example,in a TLIF procedure.

In the embodiments of a “rail” system illustrated in FIGS. 10A, 10B and11 herein, and discussed in greater detail above, the implant comprisesgenerally smooth outer surfaces (e.g., does not comprises teeth or otherengagement features). Since the implant will not directly contact orengage the adjacent surfaces of the vertebral members, the need forteeth, other protruding members and/or other roughened surface featuresmay not be necessary. This can advantageously simplify the design,manufacturability, cost and other aspects of the implant.

In the illustrated embodiments, the implant includes generally roundedprotruding members or features 220 along both of its lateral ends andalong both its upper and lower surfaces. Further, the protrudingfeatures 220 are generally continuous along an entire length of theimplant 200. However, in other embodiments, the implant 200 can includemore or fewer protruding features 220. The protruding features 220 caninclude any desired cross-sectional shape or configuration (e.g.,rounded, circular, oval, rectangular, triangular, other polygonal,irregular, etc.), as desired or required. Further, the protrudingfeatures 220 can extend only partially or intermittently along one orboth surfaces of the implant 200. Thus, the total number of protrudingmembers 220 (e.g., and thus, corresponding grooves or recesses in theplates 300 and guiding assembly 500) can be less or more than four(e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, more than 10, etc.), as desired orrequired. For example, in some arrangements, the protruding members 220are included only the top or the bottom of the implant 200.

According to some embodiments, as illustrated in FIG. 11, the grooves orrecesses 320 of the plates 300 can include one or more deployable teeth,spikes or other engagement features 322. For example, in one embodiment,the teeth or other features 322 are configured to be pushed through thebottom of the corresponding groove or recess 320, at least partially,when the protruding member or feature 220 of the implant 200 is movedover such teeth or features 322. Thus, the teeth, spikes or otherengagement features 322 can be sequentially deployed away from theimplant and toward the adjacent vertebral member. In some embodiments,the teeth or other engagement features 322 are deployed within thenative tissue of the vertebral member to help secure the plates withinthe target intervertebral space during and after implantation. Oneschematic embodiment of an implant 200 that has passed within upper andlower plates 300 and has caused a number of teeth, spikes or otherengagement features 322 to deploy away from the implant 200 isillustrated in FIG. 12.

As discussed in greater detail herein, after the implant 200 has beenproperly positioned between the plates 300 of the system, one or morescrews or other fasteners can be used to further strengthen andreinforce the system. For example, as illustrated in FIG. 13, upper andlower screws S can be positioned through one or both of the plates 300and/or the implant 200. Such screws can be advanced through one or morecortical structures of the adjacent vertebral members of the subject toprovide additional strength and support to the fusion system. In someembodiments, one or more washers, plates or other rigid or semi-rigidmembers P can also be used in conjunction with the screws or otherfasteners S. For example, the plate or other member P can include one ormore holes or other openings that are sized, shaped, oriented and/orotherwise configured to secure a screw or other fastener therethrough,as desired or required. In some embodiments, the plate P is sized,shaped and configured to be flush or substantially flush with adjacentsurfaces of the upper and lower vertebrae.

To assist in the description of the disclosed embodiments, words such asupward, upper, bottom, downward, lower, rear, front, vertical,horizontal, upstream, downstream have been used above to describedifferent embodiments and/or the accompanying figures. It will beappreciated, however, that the different embodiments, whetherillustrated or not, can be located and oriented in a variety of desiredpositions.

Although several embodiments and examples are disclosed herein, thepresent application extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinventions and modifications and equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the inventions. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combine with or substituted for one another in orderto form varying modes of the disclosed inventions. Thus, it is intendedthat the scope of the present inventions herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

While the inventions are susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the inventions are not to be limited to the particularforms or methods disclosed, but, to the contrary, the inventions are tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the various embodiments described and theappended claims. Any methods disclosed herein need not be performed inthe order recited. The methods summarized above and set forth in furtherdetail below describe certain actions taken by a practitioner; however,it should be understood that they can also include the instruction ofthose actions by another party. Thus, actions such as “advancing animplant” include “instructing advancing an implant.” The rangesdisclosed herein also encompass any and all overlap, sub-ranges, andcombinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “about” or “approximately” includethe recited numbers. For example, “about 10 mm” includes “10 mm.” Termsor phrases preceded by a term such as “substantially” include therecited term or phrase. For example, “substantially parallel” includes“parallel.”

What is claimed is:
 1. A method of inserting a spinal implant within anintervertebral space defined between an upper vertebral member and alower vertebral member, the method comprising: positioning a platesystem of the spinal implant within the intervertebral space, whereinthe plate system comprises an upper plate and a lower plate; andadvancing an insert of the spinal implant between the upper plate andthe lower plate so that the insert is urged into the intervertebralspace, the upper plate engages the upper vertebral member, and the lowerplate engages the lower vertebral member; wherein, upon advancement ofthe insert between the upper and lower plates, the upper vertebralmember is distracted relative to the lower vertebral member; and whereinadvancing the insert between the upper plate and the lower platecomprises advancing the insert at least partially using a guidingassembly, the guiding assembly comprising upper and lower guidingmembers or plates and a proximal end comprising a housing and anactuator extending through the housing, wherein proximal ends of theupper and lower guiding members are secured to the housing, and whereinthe upper and lower guiding members or plates are configured toremovably attach to the upper and lower plates of the plate system toform a pathway.
 2. The method of claim 1, wherein the actuator comprisesa mechanical device.
 3. The method of claim 1, wherein the actuatorcomprises a pneumatic device.
 4. A spinal fusion system comprising: aspinal implant comprising an endplate system and an insert; wherein theendplate system comprises an upper endplate and a lower endplate; aninsert configured to be advanced and positioned between the upperendplate and the lower endplate to secure the spinal implant within atarget intervertebral space; and a guiding assembly comprising upper andlower guiding members or plates and a proximal end comprising a housingand an actuator extending through the housing, wherein proximal ends ofthe upper and lower guiding members are secured to the housing, andwherein the upper and lower guiding members or plates are configured toremovably attach to the upper and lower plates of the plate system toform a pathway; wherein, when the insert is advanced between the upperendplate and the lower endplate, the upper endplate is configured to atleast partially contact the upper vertebral member, and the lowerendplate is configured to at least partially contact the lower vertebralmember; and wherein, upon advancement of the insert between the upperand lower endplates, the upper vertebral member is distracted relativeto the lower vertebral member.
 5. The system of claim 4, wherein atleast one of the upper endplate and the lower endplate comprises atleast one deployable engagement member configured to engage a portion ofthe adjacent vertebral member when the insert has been advanced betweenthe upper and lower endplates.
 6. The system of claim 5, wherein the atleast one engagement member comprises a tooth, spike or barb.
 7. Thesystem of claim 4, wherein the insert is configured to be advancedbetween the upper and lower endplates using a rail system.
 8. A spinalfusion system comprising: a spinal implant comprising upper and lowerendplates and an insert configured to be positioned between the upperand lower endplates; wherein the insert is configured to be advanced andpositioned between the upper endplate and the lower endplate to securethe implant within a target intervertebral space of a subject, thetarget intervertebral space extending between an upper vertebral memberand a lower vertebral member of the subject; and a guiding assemblycomprising an upper guiding member, a lower guiding member and anactuator, wherein the upper guiding member is configured to removablycouple to the upper endplate, and wherein the lower guiding member isconfigured to removably couple to the lower endplate to form a pathwaybetween the guiding members and between the endplates; wherein theactuator is configured to exert a force on the insert to advance theinsert through the pathway and between the upper and lower endplates,wherein the insert includes at least one alignment feature to helppredictably move the insert relative to the guiding members and theendplates as the insert is being advanced to the target intervertebralspace; wherein, when the insert is advanced between the upper endplateand the lower plate, the upper endplate is configured to contact theupper vertebral member and the lower endplate is configured to contactthe lower vertebral member; and wherein, upon advancement of the insertbetween the upper and lower endplates, the upper vertebral member isdistracted relative to the lower vertebral member.
 9. The system ofclaim 8, wherein the guiding assembly comprises a housing along aproximal end of the guiding assembly, wherein the actuator is configuredto extend through the housing, and wherein proximal ends of the upperand lower guiding members are secured to the housing.
 10. The system ofclaim 8, wherein the actuator comprises a threaded rod, and wherein theactuator is configured to be moved using a mechanical advancementdevice.
 11. The system of claim 8, wherein the actuator is configured tobe moved with assistance by at least one of: a motor, a motorizeddevice, a mechanical device, an electromechanical device and a pneumaticdevice.
 12. The system of claim 8, wherein at least of the upperendplate, the lower endplate and the insert comprises titanium oranother metal or alloy.
 13. The system of claim 8, wherein at least ofthe upper endplate, the lower endplate and the insert comprises PEEK oranother thermoplastic material.
 14. The system of claim 8, wherein theactuator comprises a rod.
 15. The system of claim 14, wherein a distalend of the rod is configured to directly or indirectly contact theinsert, and wherein a handle is configured to secure to a proximal endof the rod.
 16. The system of claim 8, wherein the guiding members areconfigured to couple to and decouple form the endplates using a slidableconnection.
 17. The system of claim 8, wherein the guiding members areconfigured to couple to and decouple form the endplates using amechanical connection.
 18. The system of claim 8, wherein the at leastone alignment feature is part of a rail system of the spinal implant andthe guiding assembly.
 19. The system of claim 8, wherein at least one ofthe upper endplate and the lower endplate comprises at least onedeployable engagement member configured to at least partially penetratetissue of the adjacent vertebral member when the insert has beenadvanced between the upper and lower endplates.